For the second time in three weeks a court has denied an injunction that would have compelled a hospital to administer ivermectin to a patient seriously ill with COVID-19. We previously reported on the first of those decisions, Smith v. West Chester Hosp., LLC, 2021 WL 4129083 (Ohio Com. Pl. 2021). Today we report
Off-Label Use
Just a Few Words on Off-Label Use
Sometimes our weekly searches for what is going on in the drug and device world lead as outside the traditional products liability context that is our bread and butter. Occasionally that can be refreshing – a break from preemption and causation and TwIqbal. It’s also interesting to see how things like off-label use come…
Ivermectin and COVID-19: Seriously, y’all. Stop it.
On Monday, Bexis, laboring on Labor Day, blogged about a kooky Ohio decision ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated. The decision was kooky both medically and legally.…
More COVID Kookiness – Ivermectin Lawsuits
We’ve read recently about a court taking the unprecedented step of ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated.
Off-label use is something we know a little bit about. …
Tennessee Trial Court Holds Claims Preempted Notwithstanding Alleged Off-Label Use Of A Medical Device
Today we discuss Sherrod v. Smith & Nephew, Inc., 2021 Tenn. Cir. LEXIS 74 (Tenn. Cir. Ct. 2021), a recent Tennessee trial court decision granting the defendant device manufacturer summary judgment on preemption grounds. Notwithstanding one quibble, there is much to like about the decision.
The plaintiff, who asserted a plethora of product-liability and…
FDA Completes “Intended Use” Administrative Marathon
Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes. 80 Fed. Reg. 57756 (FDA Sept. 25, 2015). …
Banned on the Run
Can – or Should – State Tort Law Force Defendants To Prevent Off-Label Use?
The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community. Id. at 350. Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 n.5 (citation and quotation marks omitted). …
Bexis Writes Another Law Review Article On Off-Label Use
Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent: Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998). This article came to be cited twice by the United States…
Delaware Court Weighs In On Texas Law And Dismissal Ensues
Delaware is having something of a moment in the sun. Although the state’s license plates have long announced it as “The First State,” that refers to being the first to ratify the U.S. Constitution. It is the second smallest in size and sixth smallest in population of the current fifty states. The casual peruser of…